MAUDE Adverse Event Report: MPRI SPRINT QUATTRO; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number 6944-58

Device Problem Cut In Material (2454)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/17/2017

Event Type  Injury  

Event Description

It was reported that the right ventricular (rv) lead insulation was cut on the superior vena cava (svc) coil connector leg during device change out.The physician used silicon adhesive to repair the cut.The lead remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPRINT QUATTRO
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6465962
• MDR Text Key: 72065212
• Report Number: 2649622-2017-02604
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P920015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/10/2011
• Device Model Number: 6944-58
• Device Catalogue Number: 6944-58
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/17/2017
• Date Device Manufactured: 07/14/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 5554-53 LEAD, D224DRG ICD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR